FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
77753-004
Requested package NDC
77753-004-14
11-digit product format
777530004
Labeler code
77753
Product ID
77753-004_a7b22505-52d9-47fd-e053-2995a90a77b3
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
SHANDISHI Biological Technology Co., Ltd.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-08
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage77753-00477753-004-14IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
77753-004-0177753-004 ​Hand Sanitizer 70% Alcohol
77753-004-0277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-0377753-004 ​Hand Sanitizer 70% Alcohol
77753-004-0477753-004 ​Hand Sanitizer 70% Alcohol
77753-004-0577753-004 ​Hand Sanitizer 70% Alcohol
77753-004-0677753-004 ​Hand Sanitizer 70% Alcohol
77753-004-0777753-004 ​Hand Sanitizer 70% Alcohol
77753-004-0877753-004 ​Hand Sanitizer 70% Alcohol
77753-004-0977753-004 ​Hand Sanitizer 70% Alcohol
77753-004-1077753-004 ​Hand Sanitizer 70% Alcohol
77753-004-1177753-004 ​Hand Sanitizer 70% Alcohol
77753-004-1277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-1377753-004 ​Hand Sanitizer 70% Alcohol
77753-004-1477753-004 ​Hand Sanitizer 70% Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77753-004-01Hand Sanitizer12 in 1 BOXGEL121
77753-004-01Hand Sanitizer10 mL in 1 BOTTLEGEL101
77753-004-02Hand Sanitizer15 mL in 1 BOTTLEGEL151
77753-004-02Hand Sanitizer12 in 1 BOXGEL121
77753-004-03Hand Sanitizer30 mL in 1 BOTTLEGEL301
77753-004-03Hand Sanitizer12 in 1 BOXGEL121
77753-004-04Hand Sanitizer53 mL in 1 BOTTLEGEL531
77753-004-04Hand Sanitizer12 in 1 BOXGEL121
77753-004-05Hand Sanitizer60 mL in 1 BOTTLEGEL601
77753-004-05Hand Sanitizer12 in 1 BAGGEL121
77753-004-06Hand Sanitizer120 mL in 1 BOTTLEGEL1201
77753-004-06Hand Sanitizer8 in 1 BOXGEL81
77753-004-07Hand Sanitizer8 in 1 BOXGEL81
77753-004-07Hand Sanitizer236 mL in 1 BOTTLEGEL2361
77753-004-08Hand Sanitizer8 in 1 BOXGEL81
77753-004-08Hand Sanitizer250 mL in 1 BOTTLEGEL2501
77753-004-09Hand Sanitizer4 in 1 BOXGEL41
77753-004-09Hand Sanitizer473 mL in 1 BOTTLEGEL4731
77753-004-10Hand Sanitizer4 in 1 BOXGEL41
77753-004-10Hand Sanitizer500 mL in 1 BOTTLEGEL5001
77753-004-11Hand Sanitizer120 mL in 1 BOTTLEGEL1201
77753-004-11Hand Sanitizer12 in 1 BOXGEL121
77753-004-12Hand Sanitizer4 in 1 BOXGEL41
77753-004-12Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
77753-004-13Hand Sanitizer4 in 1 BOXGEL41
77753-004-13Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
77753-004-14Hand Sanitizer4 in 1 BOXGEL41
77753-004-14Hand Sanitizer3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77753-004HAND SANITIZER (ETHYL ALCOHOL) GEL [SHANDISHI BIOLOGICAL TECHNOLOGY CO., LTD.]1Legacy NDC, 28 package rows20200610_a7b1c019-b5a8-ca9d-e053-2a95a90a7724.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa7b1c019-b5a8-ca9d-e053-2a95a90a77241
581662ethanol 0.7 ML/ML Topical GelSCDa7b1c019-b5a8-ca9d-e053-2a95a90a77241
581662ethanol 70 % Topical GelSYa7b1c019-b5a8-ca9d-e053-2a95a90a77241
581662ethyl alcohol 70 % Topical GelSYa7b1c019-b5a8-ca9d-e053-2a95a90a77241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77753-004-14777530004144 BOTTLE in 1 BOX (77753-004-14) > 3780 mL in 1 BOTTLE4 bottle2020-05-200000-00-00NoNoCurrent